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Human Drugs

Apellis Files Empaveli sNDA in Rare Kidney Diseases

FDA accepts for priority review an Apellis Pharmaceuticals supplemental NDA for Empaveli (pegcetacoplan) for treating two severe and rare kidney disea...

FDA General

RFK Jr. Upends His Promise to Enhance Transparency

Despite HHS secretary Robert F. Kennedy, Jr.s promises to boost transparency at HHS and its health agencies, staff cuts now occurring will likely crip...

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Biologics

Marks Firing Challenges RFK Jr.s Fitness for Office

FDA Webview editor Jim Dickinson analyzes the firing of CBER director Peter Marks and finds it a challenge to HHS secretary and vaccine skeptic Robert...

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Human Drugs

Corcepts Relacorilant Shows Promise in Ovarian Cancer

Corcept Therapeutics says data from its pivotal Phase 3 ROSELLA trial demonstrated that relacorilant in combination with nab-paclitaxel significantly ...

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Medical Devices

Medtronic Recalls Aortic Root Cannulas

Medtronic recalls its Aortic Root Cannulas due to risks presented by unexpected loose material in the male luer used in the device.

Biologics

Smallpox/Mpox Vaccine OKd Despite CBER Turmoil

FDA approves Bavarian Nordics freeze-dried formulation of Jynneos smallpox and mpox vaccine despite concerns over CBER director Peter Marks departure ...

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Human Drugs

Vanda Files NDA for Antipsychotic Drug

Vanda Pharmaceuticals files an NDA for Bysanti (milsaperidone) for treating acute Bipolar I disorder and schizophrenia.

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Human Drugs

Imfinzi Wins Approval for Bladder Cancer

FDA approves AstraZenecas Imfinzi (durvalumab) for treating adults with muscle invasive bladder cancer.

FDA General

Trump Order Stifles Union Representation at FDA

President Trump signs an executive order to remove organized union representation from the majority of government agencies, including FDA, to make it ...

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Human Drugs

Merck Touts Data in Pulmonary Arterial Hypertension

Merck reports data from its Phase 3 ZENITH trial that showed Winrevair (sotatercept-csrk) significantly reduces the risk of major morbidity and mortal...